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DIAGNOSTICS WITH A DIFFERENCE.
Next-gen bacterial, fungal, and viral detection of pathogens in agriculture, food, and clinical diagnostics.
Founded in 2014 by nationally recognized scientists and serial entrepreneurs, PathogenDx delivers testing kits, automation & software to rapidly and accurately detect pathogens in plants, in our food supply, and in our bodies—for better health and safety.
Our proprietary Microarray technology is reshaping the potential and economics of laboratory testing in three major sectors.
D3 ARRAY™:
INTRODUCING DYNAMIC DIMENSIONAL DETECTION
Our novel proprietary technology creates a three-dimensional molecular binding architecture that transforms DNA binding and target detection.

Even with two well-established diagnostic technologies, there are instances where the sensitivity and multiplex limitation of qPCR are insufficient or the cost and timeliness of NGS are problematic. The D3 Dynamic Dimensional Detection Array can fill this gap, ideally suited to simultaneously identify up to 100 targets and delivering single-gene copy sensitivity with accompanying economies and speed.

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key features
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Rapid Multiplexed Testing
Patented D3 Array™ technology is fast, cost effective, easy to use, and highly multiplexed with over 100 targets in a single reaction—delivering highly specific, sensitive and accurate results. In contrast, our competition can detect 2 pathogens simultaneously.
• Novel 3D probe network, in solution, makes for faster and more specific binding
• Speed – fast reaction times
• Realtime hybridization
• Cost effective vs serial qPCR determinations and NGS
• Much faster than NGS
Sensitive & Specific
When multiple targets, speciation or variant detection is needed, the D3 Array™ provides far more utility than qPCR testing and far less time and cost than NGS. Gain economies and flexibility without compromising accuracy.
• No steric hindrances
• Enhanced access to probes
• Asymmetric endpoint PCR
• Increased hybridization affinity
• Single gene copy sensitivity
Broad Applicability
D3 Array™ technology is driving rapid identification and quantitation of target pathogens and other known targets (including cancer) across clinical diagnostics (both Emergency Usage Approval [EUA] & Research Use Only [RUO] applications), food processing and agriculture (e.g., cannabis testing), with new applications coming to market in 2023.
• Highly multiplexed array
• 100+ targets per reaction
• Diverse sample types
• Broad application in Food, Agriculture and Clinical Diagnostics (EUA & RUO)
The D3 Dynamic Dimensional Detection Array at Work
With enhanced probe binding, single gene copy sensitivity, and competitive economies and time-to-result, the D3 Array™ delivers advantages that promote better outcomes.
RUO assays addressing Urinary Tract Infections (UTI) infections are expected in 2023, while applications for women’s health, Sexually Transmitted Infections (STI), and bloodborne illnesses (sepsis) are expected in 2024. Learn more »
PathogenDx introduced its first food safety assay without the need for enrichment in 2020, supporting Preventive Environmental Monitoring (PEM) programs, and continues to apply its D3 Array™ to the specific requirements of poultry producers and food processors. The latest assay, SeroX, identifies the vast majority of Salmonella serotypes that cause harmful infections in a single test and in a single shift. Learn more »
PathogenDx’s initial effort in agriculture is Cannabis. The company partners with over 120 laboratories in 36 states to support regulatory compliance and integrity in legal Cannabis testing. The D3 Array™ powers the industry’s most complete testing platform, with assays for detection and quantitation of regulated pathogens, environmental testing and plant viruses such as Hop Latent Viroid. In addition, the recently introduced Octa™ AutoPrep Station simplifies and automates the Cannabis lab workflow and reduces skilled labor. Learn more »
News, events and releases
Slide 5

Protectx

A safer future isn’t just
something we wish for.

We’re creating it.

Slide 1

FASTEST GROWING.
FUTURE FORWARD.

Breakthrough Molecular Testing—recognized among Inc. Magazine’s 2022 Fastest-Growing Companies.

Slide 2

Cannabis

ONE FOR ALL.

Combined Bacterial & Fungal testing with fewer lab steps and results in just 6 hours.

Slide 3

Covid-19+Variants

NEXT-WAVE READY.

Rapid, affordable, scalable detection for pandemic response 2.0.

Slide 4

Cannabis

100+ LABS TRUST PDx.

Discover the ROI and partnership driving our growth.

Slide 4

Food

aoac-certified
certainty

Environmental monitoring—the first stage of food testing’s future.

The PathogenDx Solutions Suite

Product Safety Solutions

Description

Clinical

Diagnostics

COVID-19

Variants

RUO-Research

Use Only

Food Safety

Cannabis & Hemp

Pathogens

Detects bacterial and fungal species
(PTM Certification 012201)

For Cannabis and Hemp testing, this assay detects bacterial and fungal species in a single well and a single test. Dramatically reduces hands-on steps and cost with results in 6 hours or less. Overnight enrichment is not necessary and optional dependent on state-level testing regulations. Additional reagents available for LIVE organism testing.

Click for list of specific pathogens

PTM certified for STEC, Salmonella spp, Aspergillus Flavus, Aspergillus Fumigatus, Aspergillus Niger, and Aspergillus Terreus. Customizable to test for other pathogens including E. coli (pathogenic and non pathogenic), Listeria monocytogenes, Listeria spp, Campylobacter spp, Staphylococcus aures, and Pseudemonas aeruginosa.

Combined Bacterial and fungal detection

For detection of Aspergillus Flavus, Aspergillus Fumigatus, Aspergillus Niger, and Aspergillus Terreus, Pathogenic Ecoli and Salmonella at 1 CFU/g .

Detection of multiple Pathogens down to 1CFU

Dual Hybridization of bacterial and fungal pathogens as DetectX Bacterial and DetectX Fungal. This product will save time, consumables and reporting efforts allowing for faster turnaround time.

COVID-19 testing & surveillance

DetectX-Rv test is based on end-point reverse transcription polymerase chain reaction (RT-PCR) coupled to DNA microarray hybridization for the detection of multiple genes within the SARS-CoV-2 virus.

Viruses including SARS-CoV-2

Intended for the qualitative detection of N1 and N2 regions of SARS-CoV-2 viral genome in nasopharyngeal, nasal, and oropharyngeal swab specimens from individuals suspected of COVID-19 by their healthcare provider. This test is based on an initial reverse transcription polymerase chain reaction (RT-PCR) amplification and subsequent detection of target SARS-CoV-2 molecules by DNA microarray hybridization. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meets requirements to perform high complexity tests

SARS-CoV-2 clade variant detection

Identification of SARS-CoV-2 Clade Variants from a positive COVID-19 PCR test

All known SARS-CoV-2 Clade Variants

Identification of the following Clade Variants: UK (B.1.1.7), South African (B.1.351), Brazillian (P1, P2), California-USA (B.1.429), India (N440K)

Detection of bacterial pathogen species level testing in food matrices. Overnight enrichment or shortened enrichment will be required.

Listeria spp, L. mono, salmonella ...

Detection down to 1 CFU of Listeria spp, Listeria Monocytogenes, Pathogenic Ecoli, Campylobacter and Salmonella Enterica to 1 CFU/g.

Environmental Safety Solutions

"Early warning" Surface & Air pathogen detection

Environmental Screening test for the presence or absence of 30+ bacterial and/or fungal pathogens as well as broad class indicators. This assay can be utilized with multiple sample collection types, including but not limited to food, cannabis and agriculture products, environmental or carcass swabs, air sampling and water sampling.

Over a dozen bacterial and fungal pathogens

Bacterial Organisms
Total Aerobic Bacteria (TAB) - Pan Bacterial
Bile-Tolerant Gram-negative (BTGN)
Total Enterobacteriaceae (ENT)
Salmonella spp./ Enterobacter spp.
Salmonella spp.
Escherichia spp./Shigella spp.
Escherichia coli Pseudomonas spp. Pseudomonas aeruginosa
Listeria spp.
Campylobacter spp.
Xanthomonas spp.
Aeromonas spp.
Staphylococcus spp.
Bacillus spp.

Fungal Organisms
Total Yeast & Mold (TY&M) - Pan Fungal
Fusarium oxysporum Fusarium solani
Mucor spp.
Stachybotrys spp. Golovinomyces spp. (Powdery Mildew)
Alternaria spp.
Aspergillus fumigatus Aspergillus niger Aspergillus flavus
Botrytis spp.
Aspergillus terreus
Penicillium spp./Aspergillus spp. Penicillium spp.
Candida glabrata/Saccharomyces spp.,/Kluyveromyces spp.
Candida albicans/tropicalis
Candida albicans/dubliniensis
Cladosporium spp.
Saccharomyces spp.

"Early warning" Surface & Air SARS CoV-2 detection

The PathogenDx EnviroX-Rv uses endpoint PCR + DNA microarray technology to detect SARS-CoV-2 from stainless steel environmental sample swabs.

Viruses including SARS-CoV-2 and others

Targets N1, N2 and N3 targets of the SARS-CoV-2 viral genome for detection on stainless steel (Does not preclude detection on plastic, rubber and sealed concrete)

(PTM Certification 092001)

Performance Tested Method Status by the AOAC Research Institute for the multiplex detection of Salmonella spp., Listeria spp., and L. monocytogenes without an enrichment step. 4 different commonly used food surfaces. The assay is validated down to 1 CFU without the need for sample enrichment. Surface & Air SARS CoV-2 detection

Listeria spp, Listeria monocytogenes and Salmonella

on rubber, plastic, stainless steel and sealed concrete to 1 CFU/gram.

Quantification Solutions

Quantification for fungal pathogens
(PTM Certification 072105)

QuantX Fungal is a semi-quantitative assay for fungal species in total yeast and mold (TYM), providing results in a single shift. QuantX Fungal delivers unrivaled quantitative analysis ease for labs, expanding your client regulatory offerings (and ROI) with one simple sample prep (automated or manual) across all of your Cannabis testing assays.

Multiple Yeasts and Molds

Alternarium Candida Albicans Golovinomyces Botrytis Cladosporium
Penicillium Saccharomyces, Alternaria, Fumigatus, Flavus, Niger and Terreus

Semi-quantitative results: TYM from 100-100,000 CFU/g
From 100 to 10,000* CFU/g

*AOAC PTM-certified

Quantification for bacterial pathogens

QuantX Bacterial is a semi-quantitative assay combining analysis of four broad class indicators plus species specific detection within each broad class. QuantX Bacterial delivers unrivaled ease of analysis for labs, expanding your client regulatory offerings (and ROI) with the added benefit of one simple sample prep (automated or manual) across all of your Cannabis testing assays.

Multiple Yeasts and Molds

One test delivering semi-quantitative analysis* of:
  • Total Aerobic Bacteria (<1,000 and >100,000)
  • Bile Tolerant Gram Negative Bacteria (<100 and >1,000)
  • Total Enterobacteriaceae (<100 and >1,000)
  • Total Coliforms (<100 and >1,000)
  • *Quantified in CFU/g and reported as ranges. For example, coliforms (COL) results are reported as either: "Less than 100 CFU/g", "Between 100 and 1,000 CFU/g", or "More than 1,000 CFU/g."

Live vs. Dead

All Products

Isolation of "live" DNA for pathogen detection

Sample preparation to prevent non-viable cells from being amplified preventing false positives. This product is a supplement to current sample preparation methods.